Intrahepatic Bile Duct CancerPhase 2PUMP IVNCT06888063
Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
A Phase 2 study testing Hepatic Arterial Infusion Pump chemotherapy with floxuridin in people with Intrahepatic Bile Duct Cancer and Intrahepatic Cholangiocarcinoma (Icc), run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Bile Duct Cancer, Intrahepatic Cholangiocarcinoma (Icc), Intrahepatic Bile Duct Carcinoma
- What is being tested?
- Hepatic Arterial Infusion Pump chemotherapy with floxuridin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Nov 2024to Sep 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- ECOG or WHO performance status 0 or 1
- Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
- Patient is able to undergo a laparotomy.
- Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
- Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)
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- Absolute neutrophil count (ANC) ≥ 1.5 x 10^ 9/L
- White blood cell count (WBC) ≥ 2.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Glomerular filtration rate (GFR) ≥ 30 ml/min
- Haemoglobin (Hb) ≥ 5.5 mmol/L
- Total bilirubin ≤ 25 µmol/L
- Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations.
Who cannot join
- Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.
- Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.
- Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
- Prior hepatic radiation, ablation, or resection for iCCA.
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
- (Partial) portal vein thrombosis in future liver remnant.
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- Pregnant or lactating women.
- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- Organ allografts requiring immunosuppressive therapy.
- Serious infections (uncontrolled or requiring treatment).
- Participation in another interventional study for iCCA with survival as outcome.
- Participation in another prospective study with an interventional medical product.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Bas Groot Koerkamp, MD, PhD, +31(0)107031810, b.grootkoerkamp@erasmusmc.nl
Thomas C Zwaan, MD, +31(0)621218051, t.zwaan@erasmusmc.nl
About this study
Official title: Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial
The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:
- Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?
- Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?
- Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
- Conditions
- Intrahepatic Bile Duct Cancer, Intrahepatic Cholangiocarcinoma (Icc), Intrahepatic Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma
- Being tested
- Hepatic Arterial Infusion Pump chemotherapy with floxuridin
- Keywords
- PUMP, PUMP IV, Hepatic Arterial Infusion Chemotherapy, Hepatic Arterial Infusion Pump chemotherapy, HAIP, HAIC, Intrahepatic cholangiocarcinoma, iCCA, Floxuridin, Chemopump
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic Arterial Infusion Pump chemotherapy with floxuridinCombination product
Also called HAIP, HAIC with floxuridin, PUMP chemotherapy
Participants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months)
| Study group | Role | What they receive |
|---|---|---|
| Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy) | Experimental | Surgery + chemo pump Receives: Combination Product: Hepatic Arterial Infusion Pump chemotherapy with floxuridin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year hepatic recurrence free survival (hRFS)
The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
Measured: From pump implantation until 2 years after that surgery
Secondary outcomes (10)
Overall recurrence free survival (RFS)
The percentage of patients who do not have return of disease in the given time frame. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
Measured: From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
Overall survival (OS)
OS is defined as the interval between pump implantation and the date of death (by any cause) or date of last follow-up
Measured: From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
Post-operative complications
All complications rated Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery.
Measured: From pump implantation until 90 days after surgery
Chemotherapy related adverse events (AEs)
Chemotherapy related adverse events (AEs) will be collected if they are grade III or higher according to CTCAE version 5.0
Measured: From inclusion until 4 weeks after the end of treatment with chemotherapy
Proportion of patients started with HAIP chemotherapy
The number of patients that could receive at least 1 cycle of HAIP chemotherapy with floxuridin
Measured: From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
Quality of life: EORTC QLQ-30
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This validated instrument includes 30 items covering functional domains, symptom scales, and global health status. Scores range from 0 to 100, with higher scores on the global health and functional scales indicating better quality of life.
After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years.
Measured: From inclusion until 5 years after surgery
Quality of life: EQ-5D
After study inclusion and every 3 months (+/- 30 days) thereafter patients will be asked to complete the EuroQol 5-Dimension (EQ-5D) questionnaire, a standardized measure of health-related quality of life. The EQ-5D includes five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The resulting health state is converted into an index score ranging from 0 (equivalent to death) to 1 (perfect health), though negative scores are possible.
After 1 year of follow-up, the questionnaires will be taken annually until a maximum of 5 years.
Measured: From inclusion until 5 years after surgery
Cost-effectiveness
An assessment of the cost-effectiveness of HAIP chemotherapy for patients with iCCA will be made
Measured: From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
Predictive biomarkers in the blood for efficacy of HAIP chemotherapy
A total of five additional blood samples will be collected. These samples will be collected:
- On the day of surgery before the incision is made.
- During surgery (directly from the hepatic vein).
- Before the start of HAIP chemotherapy.
- After the last cycle of HAIP chemotherapy.
- At one year after surgery or at recurrence
Measured: From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy
Additionally, tumor tissue will be collected from the removed part of the liver during the surgery. These tissue samples will be stored for further research into biomarkers.
Measured: From resection until 25 years after (conform applicable laws)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start20 Nov 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Koningin Wilhelmina Fonds
- Responsible party
- Principal investigator, Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center
- Investigators
- Bas Groot Koerkamp, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888063
- Sponsor's protocol ID
- MEC-2024-0324
- Other IDs
- 2024-513726-33-00
- Acronym
- PUMP IV
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial
- ClinicalTrials.gov ID
- NCT06888063
- Acronym / sponsor ID
- PUMP IV / MEC-2024-0324
- Conditions
- Intrahepatic Bile Duct Cancer, Intrahepatic Cholangiocarcinoma (Icc), Intrahepatic Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma
- Keywords
- PUMP, PUMP IV, Hepatic Arterial Infusion Chemotherapy, Hepatic Arterial Infusion Pump chemotherapy, HAIP, HAIC, Intrahepatic cholangiocarcinoma, iCCA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Koningin Wilhelmina Fonds
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if additional chemotherapy by means of a chemo pump can prevent return of disease in adult patients with bile duct cancer in the liver that can be treated with surgery. The main questions it aims to answer are:
- Does addition of chemotherapy by means of a chemo pump lead to less return of disease within the liver two years after surgery?
- Does addition of chemotherapy by means of a chemo pump lead to longer survival of patients?
- Does addition of chemotherapy by means of a chemo pump lead to an increase in quality of life?
Participants will receive an implanted chemo pump, through which additional chemotherapy will be given to the liver in addition to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy) | Experimental | Combination Product: Hepatic Arterial Infusion Pump chemotherapy with floxuridinSurgery + chemo pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years or older
- ECOG or WHO performance status 0 or 1
- Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
- Patient is able to undergo a laparotomy.
- Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
Key exclusion criteria (14 listed)
- Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.
- Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.
- Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
- Prior hepatic radiation, ablation, or resection for iCCA.
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic Arterial Infusion Pump chemotherapy with floxuridinAlso: HAIP, HAIC with floxuridin, PUMP chemotherapyParticipants in this arm will receive in addition to standard care (surgery) a chemo pump. This pump will provide participants with 4 cycles of treatment with chemotherapy (Floxuridin), each lasting 4 weeks. Total treatment with chemotherapy will last 16 weeks (approx. 4 months) | Combination product | Surgery + chemo pump (Hepatic Arterial Infusion Pump chemotherapy) |
Primary outcome
Two-year hepatic recurrence free survival (hRFS)
Time frame: From pump implantation until 2 years after that surgery
The percentage of patients who do not have return of disease in the liver two years after surgery. The time frame is defined as the period between pump implantation and return of disease in the liver. A recurrence is defined as a biopsy-proven recurrent lesion or radiological evidence with cross-sectional imaging in combination with an elevated CA19.9 or CEA level in the blood samples.
10 secondary outcomes
Overall recurrence free survival (RFS)
Time frame: From pump implantation until the earliest return of disease in the body during the study (up to 5 years after inclusion)
Overall survival (OS)
Time frame: From pump implantation until death or lost to follow-up during the study (up to 5 years after inclusion)
Post-operative complications
Time frame: From pump implantation until 90 days after surgery
Chemotherapy related adverse events (AEs)
Time frame: From inclusion until 4 weeks after the end of treatment with chemotherapy
Proportion of patients started with HAIP chemotherapy
Time frame: From pump implantation until the first cycle of HAIP chemotherapy, on average between 4 and 16 weeks after implantation of the HAIP chemopump
Quality of life: EORTC QLQ-30
Time frame: From inclusion until 5 years after surgery
Quality of life: EQ-5D
Time frame: From inclusion until 5 years after surgery
Cost-effectiveness
Time frame: From implantation of the chemo pump until 2 years after (=timeframe of the primary outcome)
Predictive biomarkers in the blood for efficacy of HAIP chemotherapy
Time frame: From implantation of the chemo pump until 1 year after surgery or return of disease (whichever comes first)
Predictive biomarkers from liver tissue for efficacy of HAIP chemotherapy
Time frame: From resection until 25 years after (conform applicable laws)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided. The decision on sharing IPD has not been made within the trial team. Once this decision is made, we will update this part.
Related trials for Intrahepatic Bile Duct Cancer
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Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
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RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bas Groot Koerkamp, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hepatic Arterial Infusion Pump chemotherapy with floxuridin in people with Intrahepatic Bile Duct Cancer and Intrahepatic Cholangiocarcinoma (Icc), run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bas Groot Koerkamp, MD, PhD (+31(0)107031810, b.grootkoerkamp@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year hepatic recurrence free survival (hRFS) (time frame: From pump implantation until 2 years after that surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.